BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3984255 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15897
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND COMPLAINT OF "HEST" WAS NOT CONFIRMED BUT THE EMAX 2 PLUS MOTOR HAS ISSUES THAT COULD POSSIBLY CAUSE HEAT ISSUES. THE HOSE IS CUT/TORN AT THE MOTOR TO HOSE INTERFACE, THE MOTOR HAS THERMISTOR/FLEX CIRCUIT ISSUES, AND THE MOTOR HAS CLEANING/IMMERSION ISSUES (DETERGENT RESIDUE). THE CONDITION OF THE EMAX 2 PLUS MOTOR IS MOST LIKELY DUE TO CLEANING, IMMERSION, AND HANDLING ISSUE AT THE CUSTOMER SITE. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE WAS HEATING UP. IT IS KNOWN THAT THE DEVICE WAS USED IN SURGERY. IT IS UNK IF INJURY MEDICAL INTERVENTION OR DELAY IN SURGERY OCCURRED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663917 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1